# FDA recall Z-2126-2025

> **Encore Medical, LP** · Class II · device recall initiated 2025-06-02.

## Product

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS  Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE  Model/Catalog Number: 341-12-711  Software Version: NA  Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA

## Reason for recall

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged.  The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

## Distribution

U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

## Key facts

- **Recall number:** Z-2126-2025
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-02
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2025

## Citation

> AI Analytics. FDA recall Z-2126-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2126-2025. Source: US FDA. Licensed CC0.

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